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The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dosis bupivacaine | Active Comparator | Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height) |
|
| High dosis bupivacaine | Active Comparator | Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height) |
|
| Placebo | Placebo Comparator | Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine 0.25 % Injectable Solution | Drug | Fascia iliaca block with volume 0.11 mL x subject height |
|
| Measure | Description | Time Frame |
|---|---|---|
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement | Day 0 |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | PACU arrival |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | PACU discharge |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 6 hours |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 12 hours |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 24 hours |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 36 hours |
| Current pain assessed by numeric rating scale (NRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | PACU arrival |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | B-3600 | Belgium |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Marcaine 0.25 % Injectable Solution | Drug | Fascia iliaca block with volume 0.22 mL x subject height |
|
| Sodium chloride | Drug | Fascia iliaca block with volume 0.11 mL x subject height |
|
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with |
| 48 hours |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 2 evening |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 3 morning |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 3 evening |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 4 |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 5 |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 6 |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 7 |
| PACU discharge |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 6 hours |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 12 hours |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 24 hours |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 36 hours |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 48 hours |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 2 evening |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 3 morning |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 3 evening |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 4 |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 5 |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 6 |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 7 |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | Day 0 |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | Post block |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | PACU arrival |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | PACU discharge |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 6 hours |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 12 hours |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 36 hours |
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 48 hours |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |